ID
33543
Beschrijving
Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria
Trefwoorden
Versies (3)
- 12-12-18 12-12-18 -
- 06-06-19 06-06-19 -
- 12-06-19 12-06-19 -
Houder van rechten
GSK group of companies
Geüploaded op
12 december 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)
Study Conclusion - Interim Analysis
- StudyEvent: ODM
Beschrijving
Study Conclusion
Beschrijving
SAEs recorded up to visit 7, month 21 of Malaria-026 to be recorded in Malaria-026; SAEs recorded 1 day after Visit 7, month 21 to be recorded in Malaria-039 SAE forms.
Datatype
boolean
Beschrijving
Total number of SAEs for the Malaria 039 period only
Datatype
integer
Beschrijving
Subject Withdrawal
Beschrijving
A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit
Datatype
boolean
Beschrijving
tick one box only
Datatype
text
Beschrijving
In case of death, please specify SAE number
Datatype
integer
Beschrijving
In case of serious adverse event, specify SAE number
Datatype
integer
Beschrijving
In case of protocol violation, specify
Datatype
text
Beschrijving
In other cases, specify
Datatype
text
Beschrijving
Who made the decision
Datatype
text
Beschrijving
Date of last contact
Datatype
date
Beschrijving
Was the subject in good condition at date of last contact?
Datatype
text
Beschrijving
Investigator's Signature
Beschrijving
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datatype
date
Beschrijving
Investigator's signature
Datatype
text
Beschrijving
Investigator's name (in print)
Datatype
text
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Study Conclusion - Interim Analysis
- StudyEvent: ODM